Design Quality Engineer
Altran
 Bern, CHE , Suisse
vor 3 Tg.

Avec plus de 45'000 consultants dans le monde et générant un chiffre d’affaires d'EUR. 2.9 Mia, le Groupe Altran est le leader mondial dans les services d’ingénierie et de R&D (ER&D).

En Suisse, Altran emploie plus de 250 consultants et vise une forte croissance avec des bureaux à Zurich, Bâle, Lausanne et Genève.

Altran déploie son expertise notamment dans les secteurs suivants :

  • Sciences de la vie (Pharma, Biotech, et Dispositifs médicaux),
  • Industrie, Aéronautique, Automobile, Energie, Transports Ferroviaire,
  • Services financiers : Assurance des personnes et des biens, Assurance maladie, Réassurance, Banque
  • Secteur public
  • Titre du poste Design Quality Engineer
  • Numéro de référence 16892
  • Lieu de travail Suisse / CHE - Toutes régions /
  • Bern
  • Type de contrat CDD Temps Complet
  • Nombre minimum d’années d’expérience requis 5 ans d'expérience et plus
  • Notre offre

  • A permanent contract with the leader in innovation and high-tech engineering consulting
  • A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR.
  • 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).

  • In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
  • Vos responsabilités

    For our client, a multinational healthcare company, we are currently looking for a Design Quality Engineer, to start ASAP for a temporary contract located in Zuchwil, Switzerland.

    Duties and Responsibilities :

  • Design Quality team member focused on life cycle management activities.
  • Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement.
  • Apply statistical methods and process / design excellence tools to establish test plans as well as evaluate test data and processes.
  • Perform Gage R&R studies.

  • Conduct and lead design verification and validation activities.
  • Conduct and lead design / process failure mode effects and analysis.
  • Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions (CAPA), Complaints, Nonconforming Materials, Risk Management, etc.
  • Provide leadership in the understanding of medical device regulations to other disciplines.
  • Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
  • Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.
  • Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations.
  • Responsible of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans.
  • Votre profil

  • A minimum of a Bachelor’s degree in Engineering or related technical or scientific discipline with a minimum of 7+ years of experience in related field is required.
  • Proven exceptional written and oral presentation skills
  • Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93 / 42 / EEC, ISO13485 and ISO14971 quality requirements is required.
  • Previous Quality Engineering experience is preferred.
  • Experience in an Medical Device regulated environment
  • Strong quality engineering skills with a proven track record in design verification / validation, process verification / validation, and design / process Failure Mode and Effects Analysis is preferred.
  • Fluency in English is required, good knowledge of German would be a strong asset.
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